U.S. patent application number 17/080828 was filed with the patent office on 2021-04-29 for urethral measurement catheter.
This patent application is currently assigned to Spinal Singularity, Inc.. The applicant listed for this patent is Spinal Singularity, Inc.. Invention is credited to Derek Herrera, Jeffery S. Kasalko.
Application Number | 20210121097 17/080828 |
Document ID | / |
Family ID | 1000005328554 |
Filed Date | 2021-04-29 |
![](/patent/app/20210121097/US20210121097A1-20210429\US20210121097A1-2021042)
United States Patent
Application |
20210121097 |
Kind Code |
A1 |
Herrera; Derek ; et
al. |
April 29, 2021 |
URETHRAL MEASUREMENT CATHETER
Abstract
Described is a urinary measurement catheter (UMC), which has a
tube, a distal tip, a bulbar urethral anchor, and a bladder anchor,
and that can be used to measure anatomical profiles of the urethra.
Using the UMC according to one method comprising the following
steps can be used to measure the entire urethral length: (a) insert
the UMC through the urethra until the bladder anchor is positioned
in the bladder; (b) pulling back on the UMC until the bladder
anchor is positioned against the bladder neck; (c) mark or clamp
the UMC at the meatus, or otherwise identifying the location of the
UMC tube at the meatus; and (d) remove the UMC from the body and
measure the distance from the location of the UMC tube as
determined in step (c) at the meatus to a distal edge of the
bladder anchor.
Inventors: |
Herrera; Derek; (San
Clemente, CA) ; Kasalko; Jeffery S.; (San Clemente,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Spinal Singularity, Inc. |
San Clemente |
CA |
US |
|
|
Assignee: |
Spinal Singularity, Inc.
San Clemente
CA
|
Family ID: |
1000005328554 |
Appl. No.: |
17/080828 |
Filed: |
October 26, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
62926326 |
Oct 25, 2019 |
|
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|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 25/0074 20130101;
A61B 5/1076 20130101; A61M 25/04 20130101; A61M 2210/1089 20130101;
A61B 5/20 20130101; A61B 5/6852 20130101 |
International
Class: |
A61B 5/107 20060101
A61B005/107; A61B 5/20 20060101 A61B005/20; A61B 5/00 20060101
A61B005/00 |
Claims
1. A method for measuring total urethral length utilizing a
urethral measuring catheter ("UMC") having a tube, a distal tip, a
bulbar urethral anchor, and a bladder anchor, the method comprising
the steps of: (a) inserting the UMC through the urethra until the
bladder anchor is positioned in the bladder; (b) pulling back on
the UMC until the bladder anchor is positioned against the bladder
neck; (c) marking or clamping the UMC at the meatus, or otherwise
identifying the location of the UMC tube at the meatus; and (d)
removing the UMC from the body and measuring the distance from the
location of the UMC tube as determined in step (c) at the meatus to
a distal edge of the bladder anchor.
2. The method of claim 1 that further comprises the step of
obtaining the measurement for the bladder neck to the external
urinary sphincter by pushing forward on the UMC until resistance is
felt from the urethral anchor pressing against the external urinary
sphincter, measuring that position on the UMC, then pulling the UMC
back to where resistance is felt by the bladder anchor pressing
against the bladder sphincter, and subtracting that distance from
the distance between the urethral anchor and the bladder anchor to
obtain the measurement.
3. The method of claim 1, wherein the UMC has a tube and an outer,
flexible tube external to the tube, and a space is defined between
the tube and the outer, flexible tube.
4. The method of claim 1, wherein the bladder anchor is one or more
extendable flaps.
5. The method of claim 1, wherein the urethral anchor is a
retainer.
6. The method of claim 1, wherein the UMC further includes a tube
having gradations or markings.
7. The method of claim 5, wherein the urethral anchor comprises and
outer cover defining a cavity, and two expansion structures in the
cavity, wherein each expansion structure is configured to apply
outward force on the outer cover.
8. The method of claim 7, wherein each expansion structure is wing
shaped.
9. The method of claim 7, wherein each expansion structure extends
outward and presses against an inner wall of the outer cover.
10. The method of claim 8, wherein each expansion structure has an
intermediate section.
11. The method of claim 8, wherein each expansion structure has a
length that is at least 50% of the circumference of an inner wall
of the outer cover.
12. The method of claim 8, wherein each expansion structure has a
length that is greater than 50% of the circumference of an inner
wall of the outer cover.
13. The method of claim 8, wherein each expansion structure has an
intermediate section having a thickness that is 25% or more, or 30%
or more, or 40% or more of a thickness of the outer cover.
14. The method of claim 1 that further comprises an extendable flap
on the distal end, wherein the extendable flap has a first,
contracted position in which it is positioned against an outer wall
of a tube of the UMC, and a second, extended position in which it
extends outward from the outer wall of the tube.
15. The method of claim 14 wherein the extendable flap has a length
that is at least 30%, or at least 40%, or at least 50%, or at least
60%, or at least 70% of an outer circumference of the tube.
16. The method of claim 14, wherein the extendable flap has a
thickness that is at least 50%, at least 60%, at least 70%, at
least 80%, at least 90%, or at least 100% of a thickness of the
tube wall.
17. The method of claim 1 that further comprises a dual extendable
flap on the distal end of the UMC, wherein the dual extendable flap
has a first flap, a second, flap, a first, contracted position in
which the first flap and second flap are each positioned against an
outer wall of the tube, and a second, extended position in which
the first flap and second flap are each extend outward from an
outer wall of the tube.
18. The method of claim 3, wherein the outer, flexible tube is
configured to expand.
19. The method of claim 18, wherein the outer, flexible tube can
expand to 2-5 times its initial size.
20. The method of claim 3 that further comprises the steps of (a)
inserting fluid into the space and expanding the outer, flexible
tube until the outer, flexible tube is in contact with a body part,
and (b) measuring the diameter of the outer, flexible tube.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional
Application No. 62/926,326 entitled Urethral Measurement Catheter,
which was filed on Oct. 25, 2019, the contents of which are
incorporated herein by reference.
FIELD
[0002] This disclosure relates to devices, systems and methods that
can be used to determine the dimensions/characteristics of the
urethra, and that can also empty the bladder.
BACKGROUND
[0003] Many people have varying anatomical profiles and different
dimensions of the length, width, and shape of their urethra. The
different sizes may be a result of age, genetics, size, and/or
other factors.
[0004] Currently, methods used to measure the length, width, and
profile of the urethra include cystoscopy (using flexible or rigid
endoscopes), ultrasound, and other methods.
[0005] These dimensions can be valuable for clinicians who are
treating patients for a variety of conditions including Benign
Prostate Hyperplasia (BPH), Urinary Retention, Prostate Cancer, and
other conditions.
[0006] Some patients utilize a Foley Indwelling Catheter to empty
urine from their bladder. These catheters may remain positioned in
the body up to 30 days and utilize a balloon in the bladder to
retain them in place.
[0007] The Foley Indwelling Catheter is relatively simple to use.
One major drawback to its design is that the balloon must be
inflated inside of the bladder. If the balloon is inflated anywhere
in the urethra there is a chance for serious damage and trauma to
the urethra that may result in significant injury to the
patient.
[0008] Such trauma may be difficult to treat and require
urethrotomy or other invasive techniques. In some cases, this
incident has led and/or contributed to patient death.
[0009] Another key challenge with the Foley Indwelling Catheter is
that once the balloon is inflated any forces on the tube may result
in trauma to the bladder neck. If the collection bag or exposed
tubing is caught on anything then the catheter may be ripped from
the body causing significant trauma to the patient.
[0010] Another similar trauma that patients experience is with
individuals experiencing cognitive decline or other neurological
disorders like Alzheimer's, Dementia, etc. Such patients may forget
why they have a catheter positioned in the bladder, or become
agitated and try to pull the catheter out resulting in similar
trauma as stated above.
[0011] Over time, the prolonged use of Foley Indwelling Catheters
can lead to urethral erosion and tissue damage. This is a problem
and may require invasive surgical techniques to rebuild the tissue.
The goal of these surgeries is to enable the patient to regain some
level of continence, but often these surgeries themselves have
serious challenges that threaten the wellbeing of the patient.
[0012] The following are incorporated herein by reference: U.S.
application Ser. No. 15/072,345 to Herrera et al., entitled
Extended-Use Valved Urinary Catheter, and filed on Mar. 16, 2016;
PCT Application Serial No. PCT/US2016/014648, entitled Bladder
Management Systems, and filed on Jan. 23, 2016; U.S. application
Ser. No. 15/545,903 to Herrera et al., entitled Bladder Management
System, and filed on Jul. 27, 2017; U.S. application Ser. No.
15/721,096 to Herrera et al., entitled Urinary Prosthesis Systems,
and filed on Sep. 29, 2017; U.S. Pat. No. 9,775,698, entitled
Urinary Prosthesis Systems; U.S. application Ser. No. 15/785,403 to
Herrera, entitled Extended-Use Catheters, and filed on Oct. 16,
2017; U.S. application Ser. No. 15/785,405 to Derek Herrera
entitled Catheter Mating Devices, and filed on Oct. 16, 2017; U.S.
application Ser. No. 15/785,398 to Derek Herrera entitled Catheters
and Catheter Mating Devices and Systems, and filed on Oct. 16,
2017.
SUMMARY
[0013] A such urethral measuring catheter ("UMC") having a tube, a
distal tip, a bulbar urethral anchor, and a bladder anchor, can be
configured and used to measure lengths and widths inside of the
body in which the UMC is positioned, such as in a bladder, urinary
tract, and urethra. One exemplary method according to the
disclosure for measuring total urethral length comprises the steps
of: (a) inserting the UMC through the urethra until the bladder
anchor is positioned in the bladder; (b) pulling back on the UMC
until the bladder anchor is positioned against the bladder neck;
(c) marking or clamping the UMC at the meatus, or otherwise
identifying the location of the UMC tube at the meatus; and (d)
removing the UMC from the body and measuring the distance from the
location of the UMC tube as determined in step (c) at the meatus to
a distal edge of the bladder anchor.
[0014] Another exemplary method according to the disclosure for
measuring the width and/or length of a portion of the body,
comprises the steps of: (a) inserting a UMC through the urethra
until the second anchor is positioned in the bladder; (b) moving
fluid into a flexible tube until an outer wall of the flexible tube
expands to be in contact with a surface of the body orifice in
which the tube is positioned; and (c) measuring the width of the
flexible tube when it is in contact with the surface of the body
orifice.
[0015] The respective anchors may be configured to allow for
varying distances between them to accommodate varying prostatic
urethral lengths and external urinary sphincter lengths. The total
UMC length may be sized to accommodate the patient's anatomy.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] FIG. 1 is a side view of a urethral measurement catheter
(UMC) according to this disclosure.
[0017] FIG. 2 is an enlarged side view of a UMC according to this
disclosure.
[0018] FIG. 3 is a cross-sectional view of a multi-lumen UMC
according to this disclosure.
[0019] FIG. 4 illustrates how to measure total urethral length.
[0020] FIG. 5 compares the shape of a bladder anchor of the present
disclosure to that of a Foley balloon catheter anchor.
[0021] FIG. 6 shows in cross section the male urethra and bladder
and female urethra and bladder.
[0022] FIG. 7 is a side view of the UMC of FIG. 1 with an
extendable flap 19 in its non-extended position.
[0023] FIG. 8 is a rear side, partial, perspective view of the UMC
of FIG. 7.
[0024] FIG. 9 is an end, cross-sectional view of the UMC of FIG. 8
taken through line D-D.
[0025] FIG. 10 is a partial, side, perspective view of part of the
UMC of FIGS. 8 and 9.
[0026] FIG. 11 is a partial side view of a UMC with a dual
extendable flap 190 in its extended position.
[0027] FIG. 12 is a side, end, partial, perspective view of the UMC
of FIG. 11.
[0028] FIG. 13 is a partial, side, cross-sectional view of the UMC
of FIG. 12.
[0029] FIG. 14 is a view of part of the UMC of FIG. 12 taken
through line H-H.
[0030] FIG. 15 is a side view of an exemplary embodiment of a UMC
retainer portion according to aspects of the invention.
[0031] FIG. 16 is a cross-sectional view of the retainer portion of
FIG. 15 taken along lines 3A-3A.
[0032] FIG. 17 is a cross-sectional view of the outer wall of the
retainer portion taken along line 3A-3A.
[0033] FIG. 18 is a cross-sectional view of the expansion structure
of the retainer portion shown in FIG. 16 with the expansion
structure in its expanded position.
DETAILED DESCRIPTION
[0034] The present disclosure relates to devices, systems and
methods that may use, include or be a urethral measurement catheter
("UMC") 10 designed to measure various lengths and widths of the
urethra.
[0035] In some embodiments, the UMC 10 may comprise a first anchor
19 or 290 in the bladder (also called one or more expandable flaps
19, or dual expandable flaps 290) and a second anchor 20 in the
bulbar urethra (also called a retainer or bulbar urethra anchor).
Each of the anchors 19 or 290 and 20 may have any appropriate
shape, size, material, and material properties to enable a suitable
force for insertion, removal, and to allow the UMC 10 to be
retained in the bladder once positioned correctly. The distances
between the two anchors 19 (or 290) and 20 may also enable a
clinician to estimate the lengths of portions of the urethra,
including the prostatic urethral length, external urinary sphincter
length, total urethral length, and/or combinations of these
lengths.
[0036] Each anchor 19 (or 290) and 20 can be compressed to fit
inside the adult male urethra, and to expand in portions of the
urethra that are wider and that permit the anchor to expand. One
example is the bulbar urethra, which is wider than the pendulous
urethra and external urinary sphincter. Thus, an anchor that has
been moved through the pendulous urethra expands in the bulbar
urethra. In this disclosure, the bladder anchor 19 or 290 is
positioned in the bladder and the bulbar urethra anchor 20 is
retained in the bulbar urethra when the UMC 10 is properly
positioned in the body.
Retainer Portion or Bulbar Urethra Anchor
[0037] The retainer portion 20 is positioned in the bulbar urethra
when UMC 10 is properly positioned in the lower urinary tract of a
human male. Retainer portion 20 is configured to prevent the
inadvertent migration of UMC 10 either forward or backward once UMC
10 is properly positioned in the body. If positioned in the bulbar
urethra, the retainer portion 20 is blocked by the external
sphincter to prevent inadvertent retrograde migration, and blocked
by the penile portion of the urethra to prevent inadvertent ante
grade migration. When sufficient pulling or pushing force is
applied to UMC 10, retainer portion 20 compresses from its second,
expanded position to its first, compressed position so that it can
pass through the penile portion of the penile portion of the
urethra. In this manner, UMC 10 can be removed from, or being
placed in, the lower urinary tract.
[0038] Retainer portion 20 is positioned between the distal end 18B
and the proximal end 16. Turning to FIGS. 2, 7, and 15-17, in the
embodiment shown, retainer portion 20 has (1) an outer wall 22 that
has an outer surface 22A, (2) an inner surface 22B, (3) a first,
compressed position in which it is configured to fit through the
penile urethra, and (4) a second, expanded position in which it has
a maximum cross-sectional area measured around the outer surface
22A that is at least 30% greater than the first cross-sectional
area of UMC tube 12. When in the second, expanded position,
retainer portion 20 is configured so that it cannot fit through the
penile urethra. The retainer portion 20 is configured to have a
maximum diameter of 0.3 mm to 8.0 mm when in the first, compressed
position, and is configured to have a maximum diameter of 4.0 mm to
20 mm when in the second, expanded position. Retainer portion 20
has a cavity 23 inside of the outer wall 22.
[0039] An internal structure inside of the cavity 23 includes a
core 27 and at least one expansion structure 25. The core 27 has a
passage 28, in which the tube 12 is positioned, and a wall 27B. As
shown, the at least one expansion structure 25 is connected to wall
27B of core 27, extends therefrom, and is configured to contact
inner surface 22B of the outer wall 22 and exert outward force on
the outer wall 22 to urge it towards its second, expanded
position.
[0040] In the embodiment shown, the internal structure comprising
core 27 and at least one expansion structure 25 is a single piece
made in any suitable manner, such as by molding, over-molding, or
extruding. In this embodiment, the inner structure is not formed
with outer wall 22, but is formed separately and outer wall 22 is
positioned over it. For example, tube 12 can be positioned inside
of passage 28 of core 27, and then outer cover 22 can be positioned
over tube 12 and expansion structure 25.
[0041] The retainer portion 20 as shown comprises two expansion
structures 25 in the cavity 23 and each expansion structure 25 is
configured to apply outward force on the outer cover 22. As shown,
each expansion structure 25 is wing shaped and extends outward from
the core 27. Each expansion structure 25 has a first end 25A
connected to, or integrally formed with, the core 27 and a second
end 25B that terminates in an enlarged sphere 25C. Each expansion
structure 25 has an intermediate section 28D that touches inner
wall 22B of the outer cover 22 in order to apply outward
pressure.
[0042] Each expansion structure 25 has a length (as measured from
first end 25A to second end 25B) that is at least 30%, at least
40%, or at least 50% of the circumference of the inner wall 25B of
the outer cover 22, or has a length that is greater than 50% of the
circumference of the inner wall 22B of the outer cover 22, such as
at least 60%, or at least 70%, or at least 80% of the
circumference.
[0043] Each expansion structure 25 has an intermediate section 25D
having a thickness that is 25% or more, or 30% or more, or 40% or
more of the thickness of the wall of outer cover 22 (i.e., the
thickness as measured between outer wall 22A and inner wall
22B).
[0044] The outer wall 22 of the retainer portion 20 can be
physically compressed to 1/2 or less of the maximum cross-sectional
area when subjected to a compressive force evenly applied along the
outer wall 22 of an amount from: 1-5 lbs., or 2-4 lbs., or 2-6
lbs., or 4-6 lbs., or 5-10 lbs., or 7-10 lbs., or 5-22 lbs.
[0045] Or, the outer wall 22 can be compressed from the second,
expanded position to the first, compressed position, when the outer
wall 22 is subjected to a compressive force evenly applied along
the outer wall 22 of an amount from: 1-5 lbs., or 2-4 lbs., or 2-6
lbs., or 4-6 lbs., or 5-10 lbs., or 7-10 lbs., or 5-22 lbs.
[0046] Outer cover 22 of retainer portion 20 can comprise ribs,
dimples, staples, or other structures on its outer surface to help
retain it in the bulbar urethra or other body area.
[0047] As best seen in FIGS. 15-17, the retainer portion 20 can
comprise an outer surface 22A, proximal tapered surface 24, and a
distal tapered surface 26. The proximal tapered surface 24 can be
tapered from the outer surface 22A to about the outer surface 12B
of tube 12. The distal tapered surface 26 can be tapered from the
outer surface 22A to about the outer surface 12A of tube 12. The
retainer portion has a length as measured along the longitudinal
axis X. In one embodiment the retainer portion 20 has a total
length of any amount from about: 1 cm to 10 cm, or 2 cm to 8 cm, or
3 cm to 7 cm, or 4 cm to 6 cm, and top surface 22 has a length of
any amount from about: 1 cm to 10 cm, or about 10%, about 20%,
about 30%, or about 40%, or about 50%, or about 60%, or about 70%,
or about 80%, or about 90%, or about 95%, or any amount from about
5% to 95%, of the total length of retainer portion 20.
[0048] In one exemplary embodiment, the overall length of retainer
portion 20 is about 40 mm, the overall uncompressed width at its
center is about 22 mm, the thickness of wall 25C is about 0.75 mm,
or any thickness between about 0.70 and 0.90 mm, or about 0.75 to
0.85 mm, and the radius of end 25B is about 2.0 mm, or any amount
from about 0.5 mm and 2.1 mm.
[0049] In an embodiment suitable for use in the lower urinary tract
of a human male, the maximum cross-sectional area as measured
inside of outer surface 22A (and including the cross-sectional area
of passage 28) is: (a) greater than the cross-sectional area of the
external sphincter, (b) greater than the cross-sectional area of
the penile urethra, and (c) smaller than the cross-sectional
dimension of the bulbar urethra. The maximum cross-sectional area
(as measured when retainer portion 20 is in its second, expanded
position) may be 1.2 times larger, 1.5 to two times larger, three
times as large, four times as large, five times as large, six times
as large, seven times as large, eight times as large, nine times as
large, ten times as large, or any amount from: 1.2 to five times as
large, or 1.5 to ten times as large, as the cross-sectional area
measured inside the outer surface 12B of tube 12. The maximum
cross-sectional area (as measured when retainer portion 20 is not
being compressed) may be any amount from: (24 mm).sup.2.pi. to (25
mm).sup.2.pi., (4 mm).sup.2.pi. to (25 mm).sup.2.pi., or (6
mm).sup.2.pi. to (20 mm).sup.2.pi., or (8 mm).sup.2.pi. to (16
mm).sup.2.pi., or (10 mm).sup.2.pi. to (15 mm).sup.2.pi., or (12
mm).sup.2.pi. to (15 mm).sup.2.pi., or (5 mm).sup.2.pi. to (10
mm).sup.2.pi.. In one embodiment the outer surface 22A has a
circular cross-sectional shape and has a diameter of any amount
from: 5 mm to 10 mm, or 5 mm to 7 mm, or 4 mm to 8 mm, or 6 mm to
15 mm, or 8 mm to 15 mm, or 6 mm to 20 mm, or 8 mm to 22 mm. The
diameter of surface 12B (which is the outer diameter of tube 12)
can be about 2.0 mm to 6.0 mm, or 4.6 to 6.0 mm, or any amount
from: 1.5 mm to 6.5 mm.
Bladder Anchors
[0050] The bladder anchor (e.g., the one or more extendable flaps
19 and/or dual extendable flaps 290) may also be designed in a
manner that improves post-void residual (PVR) volume. For example,
in the embodiment shown, the anchor comprises one or more
extendable flaps 19 and/or dual extendable flaps 290, rather than a
spherical balloon, so the bladder outlet is not blocked as compared
to Foley Indwelling Catheter balloons.
[0051] Both anchors 19, 20 and/or 290 may be designed with material
properties to facilitate insertion/removal by utilizing an
appropriate insertion force and removal force, while maintaining
appropriate retention forces. The anchors may include suitable
symmetric or asymmetric shapes, sizes, varying durometers and/or
materials, and be made using any suitable manufacturing method
(such as over molding or injection molding).
[0052] When a UMC 10 according to this disclosure is removed from
the body, it can be pulled out gently by using sufficient removal
force without causing unnecessary trauma to the urethra. This is
for both purposeful and accidental removals. It is not necessary to
use a syringe or other device to remove the UMC. Only appropriate
removal pressure using one's hand is required. The preferred
measure force for removal of the UMC 10 is about 0.5-5 Newtons, or
1-5 Newtons, or 0.5-2 Newtons, or 1-3 Newtons, or 1-4 Newtons, or
any amount between 0.5 Newtons and 5 Newtons.
Extendable Flap Anchor 19
[0053] The UMC may comprise an extendable flap 19 on the distal end
18, as shown in FIGS. 1B-1E. The extendable flap 19 has a first,
contracted position in which it is positioned against the outer
surface 12B of tube 12, and a second, extended position (shown in
FIGS. 7 to 14) in which it extends outward from the outer surface
12B of tube 12. The extendable flap 19 may be comprised of silicone
or other suitable, medical grade material(s).
[0054] The extendable flap 19 preferably has a length (as measured
from the position where it connects to outer wall 12B of tube 12 to
the outermost edge 19D) that is at least 20%, or at least 30%, or
at least 40%, or at least 50%, or at least 60%, or at least 70%, or
at least 80%, or at least 90%, or at least 100%, or at least 120%,
or at least 150%, or any amount from 20% to 150% of the outer
circumference of the tube 12, as measured around outer surface 12B.
The extendable flap 19 preferably has a thickness that is at least
10%, at least 20%, at least 30%, at least 40%, at least 50%, at
least 60%, at least 70%, at least 80%, at least 90%, at least 100%,
at least 110%, at least 120%, at least 130%, at least 1540%, at
least 150%, or any amount from 10% to 150% of the thickness of the
tube wall, as measured from outer surface 12B to inner surface
12A.
[0055] The extendable flap 19 may be of suitable thickness, length,
and hardness suitable for use of the UMC. For example, the flap
could utilize a 70A shore hardness with a 0.6 mm wall thickness as
measured along length L from one edge of the flap 19 to the other
as shown in FIG. 9. Flap 19 has an axial length as measured from
19A to 19B that is preferably about equal to the length, or any
amount from about 50% of the length to about 200% of the length,
such as at least 10%, at least 20%, at least 30%, at least 40%, at
least 50%, at least 60%, at least 70%, at least 80%, at least 90%,
at least 100%, at least 110%, at least 120%, at least 130%, at
least 1540%, at least 150% at least 160%, at least 170%, at least
180%, at least 190%, or at least 200%.
[0056] The extendable flap 19 may comprise a thicker portion, or
thicker ridge along each edge 19A as compared to the thickness of
the rest of dual extendable flap 19. For example, the thickness at
that location could be thicker than the thickness measured at the
center of portion 190C by any amount from 10% to 100%, such as 10%,
20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100%. This added
thickness at that location may aid the user in collapsing the dual
extendable flap 19 for insertion and also provide additional
rigidity to support proper anchoring.
[0057] Extendable flap 19 can be integrally formed with the tube 12
or formed separately and attached to tube 12. As shown in this
embodiment, extendable flap 19 is a separate component that is
pulled over tube 12, and it has a body portion 19F.
Dual Extendable Flap Anchor
[0058] The UMC may comprise a dual extendable flap 290 on the
distal end 18, as shown in FIGS. 11-14. The dual extendable flap
290 as shown has two, identical flaps 291, 291A positioned 180
degrees from one another on tube 12. Flaps 291, 291A may, however,
be positioned at any suitable location and need not be sized or
shaped the same. The dual extendable flap 190 may be comprised of
silicone or other suitable, medical grade material(s).
[0059] Each flap 291, 291A has a first, contracted position in
which it is positioned against the outer surface 12B of tube 12,
and a second, extended position (shown in FIGS. 11-14) in which
flaps 291, 291A extend outward from the outer surface 12B of tube
12.
[0060] Each flap 291, 291A of the dual extendable flap 290
preferably has a length (as measured from the position at which it
connects to outer wall 12B of tube 12 to the outermost edge 290D)
that is at least 20%, or at least 30%, or at least 40%, or at least
50%, or at least 60%, or at least 70%, or at least 80%, or at least
90%, or at least 100%, or at least 120%, or at least 150%, or any
amount from 20% to 150% of the outer circumference of the tube 12,
as measured around outer surface 12B. Each flap 291, 291A
preferably has a thickness at portion 290C that is at least 10%, at
least 20%, at least 30%, at least 40%, at least 50%, at least 60%,
at least 70%, at least 80%, at least 90%, at least 100%, at least
110%, at least 120%, at least 130%, at least 1540%, at least 150%,
or any amount from 10% to 150% of the thickness of the tube wall,
as measured from outer surface 12B to inner surface 12A.
[0061] Each flap 291, 291A may be of suitable thickness, length,
and hardness suitable for use of the UMC 10. For example, the dual
extendable flap 290 could utilize a 70 A shore hardness with a 0.6
mm wall thickness as measured along length L in section 190C. Each
flap 291, 291A has an axial length as measured from 290A to 290B
that is preferably about equal to the length, or any amount from
about 50% of the length to about 200% of the length, such as at
least 10%, at least 20%, at least 30%, at least 40%, at least 50%,
at least 60%, at least 70%, at least 80%, at least 90%, at least
100%, at least 110%, at least 120%, at least 130%, at least 1540%,
at least 150% at least 160%, at least 170%, at least 180%, at least
190%, or at least 200%.
[0062] The dual extendable flap 290 may comprise a thicker portion,
or thicker ridge along each edge 290A as compared to the thickness
of the rest of dual extendable flap 290. For example, the thickness
at that location could be ticker than the thickness measured at the
center of portion 290C by any amount from 10% to 100%, such as 10%,
20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100%. This added
thickness at that location may aid the user in collapsing the dual
extendable flap 290 for insertion and also provide additional
rigidity to support proper anchoring.
[0063] Further, each extendable flap 291, 291A as should has a bulb
290E at its respective tips. The bulb 290E as shown is circular in
cross section and has a diameter that is greater than the thickness
of section 290C. For example, each bulb 290E could be have a
diameter that is any amount from 10% to 200% greater than the
thickness of section 290C, such as being greater by at least: 10%,
20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 100%, 120%, 130%,
140%, 150%, 160%, 170%, 180%, 190%, or 200%.
[0064] Dual extendable flap 290 can be integrally formed with the
tube 12 or formed separately and attached to tube 12. As shown in
this embodiment, dual extendable flap 190 is a separate component
that is pulled over tube 12, and it has a body portion 190F.
Use
[0065] The anchors may also be designed such that the anchor in the
bladder (e.g., the one or more extendable flaps 19 and/or dual
extendable flaps 290) can pass through the external urinary
sphincter and the anchor in the bulbar urethra (e.g., the retainer
20) is configured not to pass through the external urinary
sphincter. This design may enable clinicians to identify the point
at which the anchor in the bulbar urethra and/or the anchor in the
bladder is at or near the external urinary sphincter.
[0066] The distance from the anchor 20 in the bulbar urethra to the
proximal end 16 of the UMC 10 is long enough so the proximal end
extends beyond the tip of the penis, and preferably at least
1''-4'' beyond the tip, so that the proximal end 16 of the UMC 10
is outside OF the body when the distal end 18B of the UMC 12 and
the bladder anchor 19 or 290 is properly positioned in the bladder.
The UMC 10 may also have an appropriate shape (similar to a Foley
Indwelling Catheter) at the proximal end 16 (i.e., the end that is
positioned outside of the penis tip) that allows a patient to
secure the proximal end 16 of the UMC 10 to the body.
[0067] There is also preferably no valve in the tube lumen 14 so
the UMC 10 has an unrestricted lumen that allows for continuous
drainage of urine once opening(s) 18A at the distal end 18B of the
UMC 10 that open into the lumen 14 are inside of the bladder.
Clinicians may then advance the UMC 10 an additional 2-3 cm to
ensure the bladder anchor (e.g., the one or more extendable flaps
19 and/or dual extendable flaps 290) are seated inside the bladder.
The bladder anchor 19 or 290 provides appropriate removal force to
retain the device in the bladder during use.
[0068] The UMC 10 may be designed to allow for extended use of up
to thirty days in the body.
Measuring Widths
[0069] Utilizing the UMC 12, the width of the urethra could be
measured by using different sized bladder anchors (e.g., the one or
more extendable flaps 19 and/or dual extendable flaps 290), which
would function as a go/no-go gauge through various orifices.
Another method of measuring widths, or diameters, utilizing the UMC
10 is to include an additional tube (or tubes) comprised of soft
material that run the length of the UMC 10. In one embodiment shown
in FIG. 3, the additional one or more tubes 13 would surround the
tube 12 of the UMC 10, and define an inner lumen 13A that is
outside of the UMC 10 tube wall 12B. Fluid could be injected into
the inner lumen 13A and the soft material and would be visible
under fluoroscopy. For example, fluid could be injected (preferably
at a known pressure) to expand the soft tube wall 13 to the
diameter of the orifice, such as the urethra, in which the UMC 10
is positioned. Then the fluid in lumen 13A could be imaged and
measured to determine the width of the urethra or other
orifice.
Measuring Lengths
[0070] A UMC 10 may be used in a procedure that permits clinicians
to obtain measurements for the total urethral length, prostatic
urethra length, and bladder neck to external urinary sphincter
length.
[0071] To obtain the total urethral length the clinician may gently
pull back on the UMC 10 once the distal end 18 and bladder anchor
19 or 290 are inserted in the bladder to confirm the bladder anchor
19, 290 is seated at the bladder neck. The clinician may then
mark/clamp or otherwise identify the location of the tube 12 at the
meatus. When the UMC 10 is removed from the body, the measurement
for total urethral length may be obtained by measuring the distance
from the mark on tube 12 where the meatus was identified to the
distal edge of the bladder anchor 19 or 290. Another way to
determine the total urethral length is to measure from the mark of
the meatus on tube 12 (made as described above) to the distal tip
18B of the UMC and subtract the distance from the distal tip 18B to
the distal-most part of the bladder anchor 19 or 290. Another way
to obtain the total urethral length is to measure from the mark of
the meatus on tube 12 (made as described above) to the distal tip
18B of the UMC 10, subtract that amount from the total overall
length of the UMC tube 12, and then subtract the distance of the
distal UMC tip 18B to the distal edge of the bladder anchor 19 or
290.
[0072] To obtain the measurement for bladder neck to external
urinary sphincter, a clinician may push the UMC 10 forward and
determine the position at which resistance is detected from the
first anchor (e.g., the retainer 20) pressing against the external
urinary sphincter. The clinician would then pull back to where
resistance is felt by the bladder anchor 19 or 290 against the
bladder sphincter. This distance can then be subtracted from the
distance between the two anchors 20 and 19 or 290 to obtain the
measurement.
[0073] The prostatic urethra length may be measured by utilizing
the distance between the two anchors 20 and 19 or 290. The
clinician may insert the UMC 10 and confirm the bladder anchor 19
or 290 is properly seated inside the bladder at the bladder neck.
This would be Position X. Then the clinician can apply force to
push the UMC 10 deeper into the bladder and identify how far the
UMC can be inserted before resistance is felt when the urethral
anchor 20 reaches the external urinary sphincter. This would be
Position Y. The clinician may subtract the distance between
Position X and Position Y from the distance between the urethral
anchor 20 and the bladder anchor 19 or 20 to obtain the prostatic
urethra length plus the external urinary sphincter length. Known
estimates for the external urinary sphincter length range from
0.5-1.5 cm so this distance may be subtracted from the distance
between the urethral anchor 20 and the bladder anchor 19 or 290 to
obtain an estimate of the prostatic urethra length.
[0074] Turning to FIGS. 4 and 6, the external urinary sphincter is
a portion of the urethra that is just distal to the prostatic
portion of the urethra. The distance that the UMC 10 is measuring
in the instance discussed above is equal to the distance of the
prostatic urethra+the distance of the external urinary sphincter.
One example of this would be prostatic urethra length=4.5 cm, and
external urinary sphincter length=1.0 cm
[0075] In this instance, the measurement the UMC 10 would provide
using the steps outlined in this application would be 5.5 cm. So in
this application "prostatic urethra length plus external urinary
sphincter length" means the addition of the lengths of each segment
of the urethra.
[0076] In one embodiment, gradations and markings using extrusion
molding techniques or pad printing, or any suitable method, can be
visible/tactile on the outer surface of the UMC 10 tube 12 to
facilitate length measurements. The markings/gradations may follow
a simple numbering scheme (0-40 cm) and/or may also include colors
to aid in visual identification and to lessen error in
measurement.
[0077] The UMC 10 may also serve similar functions for the female
anatomy and be sized to account for the varying anatomical
differences.
Anchoring Outside of the Body
[0078] In some embodiments, the proximal end 16 of the UMC 10 may
have a shape that is similar to the Foley Indwelling Catheter near
the proximal tip. Such a design may permit the UMC 10 to be
anchored to the outside of the body using standard adhesive
mounting methods that are similar to Foley Indwelling Catheters.
This assists with securement of the UMC 10 and helps to minimize
any accidental or unnecessary removals.
SOME NON-LIMITING EXEMPLARY EMBODIMENTS OF THIS DISCLOSURE
Example 1
[0079] A method for measuring total urethral length utilizing a
urethral measuring catheter ("UMC") having a tube, a distal tip, a
bulbar urethral anchor, and a bladder anchor, the method comprising
the steps of: [0080] (a) inserting the UMC through the urethra
until the bladder anchor is positioned in the bladder; [0081] (b)
pulling back on the UMC until the bladder anchor is positioned
against the bladder neck; [0082] (c) marking or clamping the UMC at
the meatus, or otherwise identifying the location of the UMC tube
at the meatus; and [0083] (d) removing the UMC from the body and
measuring the distance from the location of the UMC tube as
determined in step (c) at the meatus to a distal edge of the
bladder anchor.
Example 2
[0084] A method for measuring the total urethral length utilizing a
urethral measuring catheter ("UMC") having a tube, a distal tip, a
bulbar urethral anchor, and a bladder anchor, the method comprising
the steps of: [0085] (a) inserting the UMC through the urethra
until the bladder anchor is positioned in the bladder; [0086] (b)
pulling back on the UMC until the bladder anchor is positioned
against the bladder neck; [0087] (c) marking or clamping the UMC at
the meatus, or otherwise identifying the location of the UMC tube
at the meatus; and [0088] (d) removing the UMC from the body and
measuring the distance from the location of the UMC tube as
determined in step (c) at the meatus to the distal end of the
UMC.
Example 3
[0089] A method for measuring the total urethral length utilizing a
urethral measuring catheter ("UMC") having a tube, a distal tip, a
bulbar urethral anchor, and a bladder anchor, the method comprising
the steps of: [0090] (a) inserting the UMC through the urethra
until the bladder anchor is positioned in the bladder; [0091] (b)
pulling back on the UMC until the bladder anchor is positioned
against the bladder neck; [0092] (c) marking or clamping the UMC at
the meatus, or otherwise identifying the location of the UMC tube
at the meatus; and [0093] (d) removing the UMC from the body and
measuring the distance from the location of the UMC tube as
determined in step (c) at the meatus to a distal tip of the UMC,
and subtracting from that the distance from the distal UMC tip to
the distal edge of the UMC.
Example 4
[0094] The method of example 1 that further comprises the step of
obtaining the measurement for the bladder neck to the external
urinary sphincter by pushing forward on the UMC until resistance is
felt from the urethral anchor pressing against the external urinary
sphincter, measuring that position on the UMC, then pulling the UMC
back to where resistance is felt by the bladder anchor pressing
against the bladder sphincter, and subtracting that distance from
the distance between the urethral anchor and the bladder anchor to
obtain the measurement.
Example 5
[0095] A method for obtaining the measurement for the bladder neck
to external urinary sphincter, utilizing a urethral measuring
catheter ("UMC") having a tube, a urethral anchor and a bladder
anchor, the method comprising the steps of: [0096] (a) inserting
the UMC through the urethra until the second anchor is positioned
in the bladder; [0097] (b) pushing forward on the UMC until
resistance is felt from the urethral anchor pressing against the
external urinary sphincter and marking or determining that position
on the UMC; [0098] (c) pulling back on the UMC until the second
anchor is positioned against the bladder sphincter and marking or
clamping the UMC at the meatus, or otherwise identifying the
location of the UMC tube at the meatus; and [0099] (d) subtracting
the distance between the markings in (b) and (c) from the distance
between the urethral anchor and the bladder anchor.
Example 6
[0100] A method for measuring the width of a portion of the body
that utilizes an expandable tube, the method comprising the steps
of: [0101] (a) inserting a UMC through the urethra until the second
anchor is positioned in the bladder; [0102] (b) moving fluid into
the flexible tube until an outer wall of the flexible tube expands
to be in contact with a surface of the body orifice; and [0103] (c)
measuring the width of the flexible tube when it is in contact with
the surface of the body orifice.
Example 7
[0104] The method of example 6, wherein the flexible tube is
external to a tube of a UMC.
Example 8
[0105] The method of example 6, wherein the flexible is external to
and coaxial with a tube of a UMC.
Example 9
[0106] The method of any of examples 1-8, wherein the bladder
anchor is one or more wings.
Example 10
[0107] The method of any of examples 1-9, wherein the urethral
anchor is a retainer.
Example 11
[0108] The method of any of examples 1-10, wherein the UMC further
includes gradations or markings.
Example 12
[0109] A urethral measuring catheter ("UMC"), comprising (a) a
tube, (b) a first end, (c) a second end, (d) a retainer portion
between the distal end and the proximal end, the retainer portion
having (i) an outer wall that has an outer surface, an inner
surface, a first, compressed position in which it is configured to
fit through the penile urethra, and a second, expanded position in
which it has a maximum cross-sectional area at least twice as great
as the first cross-sectional area and is configured to not fit
through the penile urethra, (ii) a cavity inside of the outer wall,
(iii) a core inside of the cavity, the core having a passage in
which the tube is positioned, and (iv) at least one expansion
structure positioned inside of the cavity, the at least one
expansion structure being connected to the core and being
configured to contact an inner surface of the outer wall and exert
outward force on the outer wall, retainer portion is configured to
fit in the penile urethra, and a second dimension in which the
second compressible anchor is too large to fit in the penile
urethra.
Example 13
[0110] The UMC of example 12 that further includes gradations or
markings.
Example 14
[0111] The UMC of example 13 that is formed using extrusion
molding.
Example 15
[0112] The UMC of example 13 that is formed using pad printing.
Example 16
[0113] The UMC of example 13, wherein the graduations/markings are
on the outer surface of the UMC tube and are colored.
Example 17
[0114] The UMC of example 13 or 16, wherein the graduations are
tactile.
Example 18
[0115] The UMC of example 12, wherein the tube further comprises
(i) a wall with an outer surface, the outer surface having a first
cross-sectional area, (ii) a lumen, (iii) a distal end with one or
more openings in communication with the lumen, and (iv) a proximal
end with an opening in communication with the lumen.
Example 19
[0116] The UMC of example 12 or 18 that further comprises a valve
that is operated to be in (i) a closed configuration, wherein fluid
cannot flow out of the proximal end, or (ii) an open configuration
in which fluid can flow out of the proximal end; and
Example 20
[0117] The UMC of any of examples 12-19, wherein the retainer
portion has a maximum cross-sectional area that is 2-3 times
greater than the first cross-sectional area.
Example 21
[0118] The UMC of any of examples 12-20, wherein the retainer
portion has a maximum cross-sectional area that is 1.5-4 times
larger than the first cross-sectional area.
Example 22
[0119] The UMC of any of examples 12-21, wherein the maximum
cross-sectional area is an area from: (24 mm)2.pi. to (25 mm)2.pi.,
or (4 mm)2.pi. to (25 mm)2.pi..
Example 23
[0120] The UMC of any of examples 12-22, wherein the retainer
portion is circular in cross-section at its maximum cross-sectional
area, and has a diameter of 5 mm to 10 mm at the position of the
maximum cross-sectional area.
Example 24
[0121] The UMC of any of examples 12-23, wherein the retainer
portion has a hardness of an amount from: 1 to 70 Shore A, or 5-15
Shore A, or 10-20 Shore A, or 5-15 Shore A, or 10-15 Shore A.
Example 25
[0122] The UMC of any of examples 12-24, wherein the retainer
portion is comprised of silicone.
Example 26
[0123] The UMC of any of examples 12-25, wherein the outer wall of
the retainer portion can be physically compressed to 1/2 or less of
the maximum cross-sectional area when subjected to a compressive
force evenly applied along the outer wall of an amount from: 3-5
lbs., or 2-4 lbs., or 1-6 lbs., or 4-6 lbs., or 5-10 lbs., or 7-10
lbs., or 5-22 lbs.
Example 27
[0124] The UMC of any of examples 12-26, wherein the outer wall can
be compressed from the second, expanded position to the first,
compressed position, when the outer wall is subjected to a
compressive force evenly applied along the outer wall of an amount
from: 3-5 lbs., or 2-4 lbs., or 1-6 lbs., or 4-6 lbs., or 5-10
lbs., or 7-10 lbs., or 5-22 lbs.
Example 28
[0125] The UMC of any of examples 12-27, wherein the retainer
portion is configured to have a maximum diameter of 0.3 mm to 8.0
mm when in the first, compressed position, and configured to have a
maximum diameter of 4.0 mm to 15 mm when in the second, expanded
position.
Example 29
[0126] The UMC of any of examples 12-27 that further includes one
or more sensors on or in the UMC.
Example 30
[0127] The UMC of example 29 that is configured such that the one
or more sensors are positioned in a bladder when the UMC is
positioned in a lower urinary tract of a human male.
Example 31
[0128] The UMC of example 29 or 30, wherein the one or more sensors
are positioned at least partially in the lumen.
Example 32
[0129] The UMC of any of examples 29-31, wherein the one or more
sensors are configured to collect data of the patient, the data
comprising one or more of: fluid pressure inside of the bladder,
fluid volume inside of the bladder, temperature inside of the
bladder, acidity of urine, bacteria level and type in urine,
chemical composition of urine, motion of the patient, location of
the patient, and fluid flow when emptying the bladder.
Example 33
[0130] The UMC of any of examples 12-32, wherein that includes a
second lumen and one or more antennas positioned in the second
lumen.
Example 34
[0131] The UMC of any of examples 12-33, wherein that further
includes a second lumen that includes one or more of: one or more
sensors, and one or more antennas.
Example 35
[0132] The UMC of example 33 or 34, wherein the second lumen has a
length and includes one antenna that is at least half the length of
the lumen.
Example 36
[0133] The UMC of example 33 or 35, wherein the second lumen has a
length and includes one antenna that extends at least 10% of the
length.
Example 37
[0134] The UMC of any of examples 12-33 that further includes an
antenna that is in electrical contact with the one or more
sensors.
Example 38
[0135] The UMC of example 37, wherein the antenna is physically
connected to the one or more sensors.
Example 39
[0136] The UMC of example 12, wherein the at least one expansion
structure is wing shaped.
Example 40
[0137] The UMC of example 12, wherein the retainer portion
comprises two expansion structures in the cavity and each expansion
structure is configured to apply outward force on the outer
cover.
Example 41
[0138] The UMC of example 40, wherein each expansion structure is
wing shaped.
Example 42
[0139] The UMC of example 40, wherein each expansion structure
extends outward and presses against an inner wall of the core.
Example 43
[0140] The UMC of example 12, wherein each expansion structure has
an intermediate section.
Example 44
[0141] The UMC of example 12, wherein each expansion structure has
a length that is at least 50% of the circumference of an inner wall
of the outer cover.
Example 45
[0142] The UMC of example 12, wherein each expansion structure has
a length that is greater than 50% of the circumference of an inner
wall of the outer cover.
Example 46
[0143] The UMC of example 12, wherein each expansion structure has
an intermediate section having a thickness that is 25% or more, or
30% or more, or 40% or more of a thickness of the outer cover.
Example 47
[0144] The UMC of example 12 that further comprises an extendable
flap on the distal end, wherein the extendable flap has a first,
contracted position in which it is positioned against an outer wall
of the tube, and a second, extended position in which it extends
outward from the outer wall of the tube.
Example 48
[0145] The UMC of example 47, wherein the extendable flap has a
length that is at least 30%, or at least 40%, or at least 50%, or
at least 60%, or at least 70% of an outer circumference of the
tube.
Example 49
[0146] The UMC of example 47, wherein the extendable flap has a
thickness that is at least 50%, at least 60%, at least 70%, at
least 80%, at least 90%, or at least 100% of a thickness of the
tube wall.
Example 50
[0147] The UMC of example 12 that further comprises a dual
extendable flap on the distal end, wherein the dual extendable flap
has a first flap, a second, flap, a first, contracted position in
which the first flap and second flap are each positioned against an
outer wall of the tube, and a second, extended position in which
the first flap and second flap are each extend outward from the
outer wall of the tube.
Example 51
[0148] The UMC of example 12 that has a second wall of flexible
material that defines a second lumen.
Example 52
[0149] The UMC of example 51, wherein the lumen is configured to
receive fluid.
Example 53
[0150] The UMC of example 51 or 52, wherein the second wall is
configured to expand.
Example 54
[0151] The UMC of example 53, wherein the second wall can expand to
2-3 times its initial size.
Example 55
[0152] The UMC of example 53, wherein the second wall can expand to
2-5 times its initial size.
[0153] Having thus described some embodiments of the invention,
other variations and embodiments that do not depart from the spirit
of the invention will become apparent to those skilled in the art.
The scope of the present invention is thus not limited to any
particular embodiment, but is instead set forth in the appended
claims and the legal equivalents thereof. Unless expressly stated
in the written description or claims, the steps of any method
recited in the claims may be performed in any order capable of
yielding the desired result. No language in the specification
should be construed as indicating that any non-claimed limitation
is included in a claim. The terms "a" and "an" expressly used in
the context of describing the invention (especially in the context
of the following claims) are to be construed to cover both the
singular and the plural, unless otherwise indicated herein or
clearly contradicted by context.
* * * * *